Hello All,
I was wondering if anyone is able to provide input (guidance) on the following:
We have a physiomonitoring system that is intended for complete physiologic/hemodynamic monitoring (i.e. ECG, CO2, NIBP, etc.). If we state the device is indicated for use in "areas where cardiac monitoring may be required", can we further market the device for specific labs (while not changing the intended use)?
I appreciate your perspective(s) on this topic!
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Jim Luker RN, MS, RAC
QA/RA Engineer
Philips Medical System
Melbourne FL
United States
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